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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
510(k) Number K221425
Device Name Primary Relief
Applicant
DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo,  CA  94401
Applicant Contact Srini Nageshwar
Correspondent
DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo,  CA  94401
Correspondent Contact Srini Nageshwar
Regulation Number882.5890
Classification Product Code
NHI  
Date Received05/16/2022
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03750357
Reviewed by Third Party No
Combination Product No
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